Flexible adhesive element for external medical use in the treatment of hypertrophic or cheloid scars following breast surgery

ABSTRACT

The flexible adhesive element (100) has a profile that is generally anchor-shaped, with an essentially rectilinear central branch (101) and with two curved side branches (102, 103). The central branch (101) is designed to extend to the peri-areolar zone of the breast concerned so as to cover said zone, and the two side branches (102, 103) are designed to extend along the fold beneath the breast to cover said fold at least in part.

The present invention relates to a flexible adhesive element forexternal medical use in the treatment of hypertrophic or cheloid scarsfollowing breast surgery.

BACKGROUND OF THE INVENTION

The state of the art is illustrated by document WO-A-88 06877 whichdescribes an adhesive medical patch for protecting the nipple and theareolar zone of the breast following a surgical operation. The patch iscircular and it is held in place by four adhesive tabs in across-configuration. As a result, the zone concerned of the breast isvery limited.

To complete the state of the art, mention may also be made of otherdevices which are not for medical use, but which are designed to providesatisfactory support for the breast. These comprise, in particular,stick-on bra type devices (see for example documents FR-A-2 505 620 andU.S. Pat. No. 2,869,553) or devices of the molded shell type designed toserve as a stiffener that can be implanted in a traditional bra (see forexample document BE-A-482 682).

Breast surgery, whether for repair purposes or for reconstructionpurposes, requires the use of several types of surgical techniques, andthe surgeon selects the technique which is most suited to the shape ofthe breast. Mention can be made of the peri-areolar technique whichleaves a substantially circular scar in the areolar zone of the breast.There are also the L-technique and the T-technique which leave a scarformed by a first line going down from the peri-areolar zone of thebreast to the fold under the breast, and a second line (straight orcurved) extending along the fold under the breast, on one or both sidesof the first line. The L- or T-technique can also be combined with theperi-areolar technique, in which case the first scar line is topped by asubstantially circular scar.

Such scars are difficult to treat to obtain good appearance since thebreast is a soft organ that is difficult to compress, particularly inits peri-areolar zone. Also, patients are naturally disinclined to use arigid or semi-rigid element or a strap partially or completelysurrounding the bust in order to exert localized pressure on the scarzones.

It can then be tempting to use a flexible element of the same type as isused already for the treatment of scars in a zone of the body havingbony support, but that leads to several difficulties.

For example, flexible elements are known that are made from anon-adhesive gel based on silicone or on three-block copolymers, saidgels for medical use generally being packaged in the form of patches,bands, or strips. Such patches, bands, or strips present advantageousflexibility, but they are thick (3 mm to 5 mm in general), which spoilsappearance, and they require additional means to put them into positionand to hold them in place (adhesive strips, etc.), such that applyingsuch flexible elements to the treatment of breast scars would give riseto considerable risk of undesirable movement giving rise to poorpositioning relative to the patient's bust, and consequently to reducedtherapeutic effect. In addition, and particularly with bands, they alsoexert pressure on an area which is not limited to the scar zone that isto be treated, and that presents a major drawback of the element'socclusive effect and because of the resulting risk of maceration.Consequently, such a flexible element appears to be difficult to applyin treating scars following breast surgery.

Flexible elements are also known that are constituted by asilicone-based film having one face coated in an adhesive gel based onsilicone (see for example document U.S. Pat. No. 4,991,574). These aredressings for applying to open wounds or to scars, which dressings arecut from a rectangular patch which is generally 10 cm×15 cm. However,that type of flexible element is also relatively thick (generally atleast 3 mm to 4 mm), and of very limited flexibility; such that thetraumatizing nature of wearing such an element is further reinforcedbecause it is conspicuous. The poor flexibility of an element of thattype makes it difficult to fit to the shape of a curved or complexsurface, such that it would appear to be unsuitable for use in treatingscars following breast surgery. Its great thickness is also anunfavorable factor from the points of view of appearance and of comfort,which is particularly important for the bust area. Finally, that productis relatively fragile and its lifetime is no more than about 2 weeks,which makes it expensive.

OBJECTS AND SUMMARY OF THE INVENTION

An object of the invention is to provide a flexible adhesive element forproviding effective treatment of hypertrophic or cheloid scars followingbreast surgery, and avoiding the drawbacks of the above-mentionedflexible elements.

Another object of the invention is to provide a flexible element of theadhesive type which is effective with different types of breast scar,depending on the type of surgery performed on the patient.

More particularly, the invention provides a flexible adhesive elementfor external medical use in the treatment of hypertrophic or cheloidscars following breast surgery, the element being characterized in thatits profile is generally anchor-shaped, with an essentially rectilinearcentral branch and two curved side branches, the central branch beingdesigned to extend to the peri-areolar zone of the breast concerned soas to cover said zone, and the two side branches being designed toextend along the fold beneath the breast concerned so as to cover saidfold at least in part, with a first branch being for the portion of thefold that goes towards the sternum zone of the patient, and a secondbranch being for the portion of the fold that goes towards the axillaryzone of the patient.

Such a flexible element is thus very versatile with respect to thesurgical techniques used, whether they be peri-areolar techniques and/orL- or T-techniques. It thus becomes possible to recommend the use ofsuch a flexible adhesive element under all circumstances after breastsurgery, without requiring cutting out specific to circumstances.

Preferably, the central branch is terminated in a rounded end portioncovering all of the areolar zone of the breast concerned, and is of awidth that is essentially constant and the same as that of its roundedend portion. This ensures that the same element is equally suitable forcovering a scar whether following surgery by a peri-areolar techniqueand scar lines or following surgery by an L- or a T-technique going downfrom the peri-areolar zone of the breast to the fold beneath the breast.

Advantageously, the first side branch is shorter than the second sidebranch, the second side branch extending to the axillary zone of thepatient. In particular, the side branches are of essentially constantwidth and terminate in respective rounded end portions. The specialshape of the side branches of the flexible element thus ensures optimumcovering of the zone concerned of the fold beneath the breast for allkinds of scar following surgery implemented using an L-technique or aT-technique.

Preferably, the flexible element is constituted by a support layer onwhich there is fixed a layer of gel that is adhesive throughout. In avariant, a support layer has fixed thereon a layer of gel that isessentially non-adhesive, with the free face thereof being covered in afilm that is adhesive on its outside face.

The material constituting the support layer is selected from the groupconstituted by textile materials, optionally elastic textile materials,plastics materials, treated papers, and essentially non-adhesiveflexible gels.

In a first application of the invention, the above flexible element hasan adhesive face designed to be applied against the body of the patient,said adhesive face being optionally covered in a protective film whichis removed immediately before the flexible element is put into place.

In a variant application, the flexible element has an adhesive facewhich is designed to be applied to the inside face of a bra cup forwhich the flexible adhesive element then constitutes a lining.

BRIEF DESCRIPTION OF THE DRAWINGS

Other characteristics and advantages of the invention appear moreclearly in the light of the following description and the accompanyingdrawings, relating to particular embodiments, and in which:

FIG. 1 shows two flexible adhesive elements of the invention laid flat,and suitable for being applied respectively to a right breast and to aleft breast;

FIG. 2 shows a patient wearing an anchor-shaped flexible element of FIG.1 on each breast;

FIG. 3 is another perspective view of a patient wearing such a flexibleadhesive element on her right breast only;

FIG. 4 is a perspective view of a conventional type of bra in which bothcups are internally lined with a flexible adhesive element, eachflexible element thus constituting a lining for the cup concerned; and

FIGS. 5A, 5B, 5C, 5D, 5E, and 5F are sections on V--V through a flexibleadhesive element as shown in FIG. 1, and showing various embodiments ofsaid flexible element, with support layers of different materials andwith gel layers that are adhesive throughout or that are essentiallynon-adhesive.

MORE DETAILED DESCRIPTION

FIG. 1 shows two flexible adhesive elements 100 of the invention, theleft element being suitable for placing on a right breast and the rightelement on a left breast. Each flexible element 100 is generallyanchor-shaped, having an essentially rectilinear central branch 101 anda first curved side branch 102 and a second curved side branch 103. Inthis case, the central branch 101 terminates in a rounded end portion104, and it is of essentially constant width, which is the same as thewidth of the rounded end portion 104.

As can be seen more clearly in FIGS. 2 and 3, the central branch 101 ofthe flexible element 100 is designed to extend to the peri-areolar zoneof the breast concerned so as to cover said zone, the rounded endportion 104 covering the entire areolar zone 6 of the breast. The twocurved side branches 102 and 103 are designed to extend along the fold 5beneath the breast concerned, so as to cover said fold, at least inpart. Each flexible element 100 thus includes a the first curved sidebranch 102 for the portion of the fold beneath the breast going towardsthe sternum zone of the patient, and the second curved side branch 103for the portion of said fold that goes towards the axillary zone of thepatient. Specifically, it can be seen that the first curved side branch102 is shorter than the second curved side branch 103, which extends allthe way to the axillary zone of the patient. This asymmetry of theflexible elements does perhaps constitute a slight drawback insofar asit is necessary to make and store left elements and right elements,however this slight drawback is largely compensated by the advantage ofeach flexible element being easy to fit very accurately to themorphology of the patient. In addition, the longer side branch extendingto the axillary zone of the patient makes it possible to hold theflexible element well relative to a vertical line going down from theareola of the breast, such that said zone, and the zone connecting it tothe fold under the breast always remains properly covered by theflexible elements, in spite of the patient moving. It will also beobserved that the curved side branches 102 and 103 are of essentiallyconstant width in this case, and terminate in respective rounded endportions 105 and 106. In practice, a width is selected that issufficient to be certain of properly covering all of the portionconcerned of the fold 5 under the breast.

FIGS. 2 and 3 show a first way in which the flexible element 100 of theinvention can be used, in which the adhesive face of the flexibleelement is applied directly to the body of the patient. In this case,each flexible element holds itself in place, without there being anyneed to provide external holding means. In addition, insofar as thestructure of the flexible element is selected to be thin, this flexibleelement is extremely inconspicuous and enables the person to wear herusual bra.

In another way of using the invention, the adhesive face of the flexibleelement 100 is designed to be pressed against the inside face of a bracup so that the flexible adhesive element constitutes a lining for thebra. Such a variant is shown in FIG. 4 in which there can be seen aconventional type of bra 60 with at least one of its two cups 50 (inthis case both cups) being internally lined with a flexible adhesiveelement 100 like those described above. In this case, the, or each, cupwhich is lined with a properly positioned flexible element enables theflexible element(s) used to be positioned naturally and automatically assoon as the bra is put on. Application in this way is advantageousinsofar as it enables the patient to use her usual bra in a manner thatis so unobtrusive that, once the bra has been put on, she can forget sheis wearing a therapeutic element.

Various structures are described below with reference to FIGS. 5A to 5Fshowing embodiments of flexible adhesive elements 100 made up ofsuperposed layers.

In FIG. 5A, the flexible adhesive element 100 is constituted by asupport layer 11 made of textile material, on which there is fixed alayer 12 of gel for external medical use, which gel is adhesivethroughout. In this case, the free face, referenced 13, of the layer 12of adhesive gel is itself adhesive. As shown in FIG. 5B, it is moreconvenient in practice to provide for the free face 13 of the layer 12of adhesive gel to be covered in a protective film 15, e.g. of plasticsmaterial, which film is removed immediately before the flexible adhesiveelement 100 is put into place. It may be constituted by a simplepeel-off film analogous to those found on numerous adhesive products inthe medical field. The presence of such a protective film 15 isparticularly advantageous when the free face of the layer of adhesivegel is to be applied directly to the body of the patient. The textilematerial constituting the support layer 11 may be made of cloth, andoptionally an elastic cloth, thereby obtaining a flexible element whichis also compressive.

Although several adhesive gels can be envisaged for making the layer 12of gel that is adhesive throughout, there follows a description of aparticular composition of adhesive gel which has been found to beparticularly satisfactory for making the flexible adhesive element ofthe invention.

In this particular composition, the adhesive gel of the layer 12 is madefrom at least one block copolymer based on styrene and on isoprene in asolvent-forming pharmaceutical inorganic oil, and of a hydrocarbon resinused in predetermined proportion in said gel, which proportion isselected to confer the desired degree of adhesion to the gel. Theparticular above-mentioned copolymer(s) selected make it possible toobtain a gel that is soft to a greater or lesser extent, lending itselfparticularly well to being shaped three-dimensionally. Also, the amountof hydrocarbon resin selected for use in the adhesive gel makes itpossible to achieve the desired degree of adhesion that is best suitedto the particular application concerned. Preferably, a gel is used thatis made from at least one linear block copolymer based on styrene and onisoprene including about 15% by weight of styrene, said polymer or saidmixture of copolymers essentially constituting 5% to 40% by weight ofthe adhesive gel. By way of example, mention can be made specifically ofthe linear block copolymer based on styrene and on isoprene and soldunder the name KRATON D-KX 601 CS by Shell Chemical Company (KRATON® isa registered trademark of Shell). It is then preferable to use a lightparaffin oil such as the oil sold under the trademark ONDINA 15® by theShell Oil Company. The resin may be the resin under the name REGALITE R101 by Hercules S.A. (REGALITE® is a registered trademark).

FIG. 5C shows another flexible adhesive element 100 of the invention inwhich the support layer 21 is a film of plastics material, or a sheet oftreated paper (e.g. grease-proof paper). In this case, the layer of gel22 is essentially non-adhesive, so it is necessary to provide for a film24 that is adhesive on its own outside face 25 to be applied to the freeface 23 of the layer 22. The non-adhesive gel may be a gel based onsilicone or based on tri-block copolymers. By way of example, mentioncan be made of gels based on styrene-ethylene/butylene-styrene blockcopolymers in an inorganic oil. Mention may also be made of gels basedon styrene-ethylene/butylene-styrene block copolymers made using KRATON®G 1650, 1651, 1652, and 1654 (where KRATON® is a registered trademark ofShell).

FIG. 5D shows another variant in which the support layer 31 is made ofan essentially non-adhesive flexible gel, e.g. a gel of theabove-mentioned type based on styrene-ethylene/butylene-styrene blockcopolymers in a light inorganic oil. A layer 32 of gel that is adhesivethroughout is then fixed to said support layer 31. This adhesive layermay comprise the particular composition mentioned above with referenceto FIG. 5A as the gel which is adhesive throughout. In this case, thefree face 37 of the flexible element 100 is non-adhesive while the otherfree face 33 is adhesive. For the non-adhesive gel, it is possible, forexample, to use a gel such as that sold under the name KRATON G 1654 Xby Shell Chimie (KRATON® is a trademark registered by Shell). In avariant, it will be possible to use another KRATON G sold by the samecompany, such as KRATON G 1651 which differs from the above in terms ofstyrene content.

FIG. 5E shows a variant of FIG. 5D in which the free face 33 of thelayer 32 of gel that is adhesive throughout is coated in a protectivefilm 35 which is removed immediately before the flexible adhesiveelement is put into place, and the outside face 37 of the support layer31 is covered in a protective layer 38 of cloth to avoid grease marks ona garment coming into contact with the outside surface of the flexibleelement.

FIG. 5F shows another variant of FIG. 5D in which the outside face 37 ofthe support layer 31 of essentially non-adhesive flexible gel isdesigned to be applied to the zone concerned of the patient's body,while the free face 33 of the layer 32 of adhesive gel is appliedagainst the inside face of the cup 50 of a bra, so that the flexibleadhesive element then constitutes a lining therefore, as described abovewith reference to FIG. 4.

A flexible adhesive element is thus provided which is particularlyeffective in the treatment of breast scars, whatever the type oftechnique used during the surgery. In all cases, the element is pressedclosely against the skin of the patient, thereby achieving an optimumtherapeutic effect for the treatment of scars. In addition, the flexibleadhesive element is discrete and comfortable to wear because it is thinand very flexible, providing advantageous components are selected suchas those given above by way of example.

The invention is not limited to the embodiments described above, but onthe contrary covers any variant reproducing the essentialcharacteristics mentioned above by using equivalent means.

I claim:
 1. A flexible adhesive element for external medical use in thetreatment of hypertrophic or cheloid scars following breast surgery,comprising an adhesive element having a generally anchor-shaped profile,with an essentially rectilinear central branch together with first andsecond curved side branches, said central branch being adapted to extendto a peri-areolar zone of a breast so as to cover said peri-areolar zoneduring use, and said first and second curved side branches being adaptedto extend along a fold beneath said breast when in use so as to coversaid fold at least in part, with said first branch being adapted toextend along one portion of the fold in a direction of a sternum zone ofthe patient, and said second branch being adapted to extend alonganother portion of the fold in a direction of and up to an axillary zoneof the patient, said first curved side branch being shorter than saidsecond curved side branch, and each of said first and second curved sidebranches being of essentially constant width and terminating inrespective round end portions.
 2. The flexible element according toclaim 1, wherein the central branch is terminated in a rounded endportion adapted to cover all of an areolar zone of said breast duringuse.
 3. The flexible element according to claim 2, wherein the centralbranch has a width that is essentially constant and the rounded endportion thereof has a maximum width that is equal to the width of saidcentral branch.
 4. The flexible element according to claim 1 wherein itis constituted by a support layer on which there is fixed a layer of gelthat is adhesive throughout.
 5. The flexible element according to claim1, wherein it is constituted by a support layer on which there is fixeda layer of gel that is essentially non-adhesive, with the free facethereof being covered by a film that is adhesive on its outside face. 6.The flexible element according to claim 4 or 5, wherein the materialconstituting the support layer is selected from the group consisting oftextile materials, elastic textile materials, plastics materials,treated papers and essentially non-adhesive flexible gels.
 7. Theflexible element according to claim 4 or 5, wherein it has an adhesiveface adapted to be applied against the body of the patient in use. 8.The flexible element according to claim 7 wherein said adhesive face iscovered by a protective film which is adapted to be removed immediatelybefore said flexible element is applied against the body of the patient.9. The flexible element according to claim 4 or 5, wherein it has anadhesive face which is adapted to be applied to the inside face of a bracup for which the flexible adhesive element then constitutes a lining.